EP2292296A1 - Valve sans aiguille écouvillonnable - Google Patents

Valve sans aiguille écouvillonnable Download PDF

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Publication number
EP2292296A1
EP2292296A1 EP10175695A EP10175695A EP2292296A1 EP 2292296 A1 EP2292296 A1 EP 2292296A1 EP 10175695 A EP10175695 A EP 10175695A EP 10175695 A EP10175695 A EP 10175695A EP 2292296 A1 EP2292296 A1 EP 2292296A1
Authority
EP
European Patent Office
Prior art keywords
valve
swabbable
needleless valve
catheter
swabbable needleless
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP10175695A
Other languages
German (de)
English (en)
Inventor
Mehmet Tuysuz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Asset Medikal Tasarim Sanayi Ve Ticaret AS
Original Assignee
Asset Medikal Tasarim Sanayi Ve Ticaret AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Asset Medikal Tasarim Sanayi Ve Ticaret AS filed Critical Asset Medikal Tasarim Sanayi Ve Ticaret AS
Publication of EP2292296A1 publication Critical patent/EP2292296A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation

Definitions

  • the present invention relates to a swabbable needleless valve which is used for closing the end of the intravenous catheter for vascular access which extends out of the body, prevents the medical staff from contacting with the blood of the patient, has a swabbable insert surface and is suitable for the needleless fluid exchange.
  • the intravenous (IV) catheter consists of a fine plastic tubing which is inserted into the vein of a patient having a diameter of 1-1,5 mm, and a length of 20-45 mm, and a connector which is placed on this fine tubing which extends out of the body.
  • the connector is in the form of a female luer. Said female luer is for connection to the male luer of other medical devices such as sterile syringe, serum set, expansion line which are used to give medicine and fluid to the patient.
  • the end in the form of fine tubing of the intravenous catheter (distal end) is inserted into the vein of the patient by means of a guiding needle passing through the catheter. Then, the needle is removed from inside of the catheter and disposed.
  • the open end with connector (the proximal end) of the catheter which extends out of the body is closed by a cap. Depending on the course of the treatment, the cap is removed and fluid-medicament is given to the patient, blood sample is taken where necessary and then the cap is put back again.
  • the needle inside of the catheter is removed and disposed, and the end of the catheter is closed by a standard cap.
  • this cap is removed and fluid exchange is implemented. Following this process, the cap is put back on the same place again. There is probability of touching blood of the patient for the medical staff with his/her hand whenever the cap is opened. Moreover, there is a risk of contamination of the cap with the infectious agents in the environment and transmission of these infectious agents to the vein access of the patient when the cap is put back again.
  • caps with latex membrane have been used instead of conventional standard caps.
  • the caps with latex membrane are opened less frequently during the treatment, which partially protects the patient against the contagious external agents.
  • the requirement for using the latex membrane with a piercing needle cannot bring solution for the needle stick accidents.
  • the latex caps are required to be removed in order to connect a serum set to the patient.
  • the swabbable valves are used to close the end of the intravenous catheter which extends out of the body of a patient as a separate medical device.
  • a normally closed valve this valve substituting the conventional cap enables disinfection of the insert surface by wiping and fluid exchange without using a needle.
  • the valve comes into open position by activation of stub male luer of other medical devices.
  • the main principle of the valves access surface of which can be wiped is that the access surface of the valve is always in the closed position, fluid pathway is opened in both directions by inserting the male luer of another medical device into the valve, and is closed again so as not to allow contact with the environment when the male luer is removed.
  • examples for the swabbable valve concept include US Patent No: 5,676,346 , US Patent No: 5,699,821 , US Patent No: 6,036,171 , US Patent No: 6,651,956 , US Patent No: 6,039,302 , US Patent No: 6,079,432 .
  • the objective of the present invention is to realize a swabbable needleless valve which enables to essentially meet the safety need of patient and medical staff.
  • Another objective of the present invention is to realize a swabbable needleless valve which enables to provide manufacture and assembling facilities.
  • a further objective of the present invention is to realize a cost efficient swabbable needleless valve.
  • Yet another objective of the present invention is to realize a swabbable needleless valve which is ergonomic and easy to use.
  • An additional objective of the present invention is to realize a swabbable needleless valve which enables the total treatment cost to be reduced.
  • the swabbable needleless valve (1) comprises a body (5) which has an insert side (2) into which the male luer (M) of the syringe and serum sets used in the treatment are inserted, an exit side (3) which enables to be connected to the catheter and a connective region (4) which connects these two portions (2, 3) to each other, and a valve member (6) which enables control of the fluid passage.
  • a body (5) which has an insert side (2) into which the male luer (M) of the syringe and serum sets used in the treatment are inserted, an exit side (3) which enables to be connected to the catheter and a connective region (4) which connects these two portions (2, 3) to each other, and a valve member (6) which enables control of the fluid passage.
  • the body (5) consists of more than one hollow portions (2, 3, 4) in order to enable flow passage and whose diameters are varied.
  • these portions (2, 3, 4) are in the form of cylinder.
  • diameter of the connective region (4) is larger than that of the insert side (2) and diameter of the insert side (2) is larger than that of the exit side (3).
  • valve member (6) is placed into the cavity provided within the insert side (2) and the connective region (4).
  • the male luer (M) of the medical device such as sterile syringe, serum set, expansion line which are used to administer medicine and fluid to a patient is inserted into the insert side (2).
  • the valve member (6) which is provided in this portion (2) is pushed toward the connective region (4) by being compressed.
  • the insert side (2) can consist of more than one portions having the same or different diameters.
  • the connective region (4) enables connection between the insert side (2) and the exit side (3), and valve member (6) is placed inside the cavity included in the connective region.
  • the exit side (3) extends towards the catheter from the surface of the connective region (4) opposite to the insert side (2).
  • Said exit side (3) consists of portions which preferably have different geometric features.
  • the exit side (3) is composed of four portions; that is, flow cut-off portion (14), abutment portion, (15), leaning portion (16) and connection portion (17).
  • the flow cut-off portion (14) which begins below the connective region (4) has a cross section which firstly gets narrow and then gets wide.
  • both ends of the flow cut-off portion (14) have the same cross section and the same geometric shape.
  • the abutment portion (15) which begins from the end of the flow cut-off portion (14) and diameter of which is larger than that of the flow cut-off portion (14) is provided.
  • the leaning portion (16) and the connection portion (17) begin, respectively. Both of these portions (16, 17) have a constant diameter in the expansion direction and diameter of the leaning portion (16) is larger than that of the connection portion.
  • the leaning portion (16) is leaned to the wall of the catheter to be connected and prevents the catheter from proceeding farther in the exit side. That is, the leaning portion (16) acts as a stopper for the catheter.
  • the connection portion (17) is inserted into the female luer of the catheter, and enables the fluid which passes through the hollow inside of the same to be transmitted to the catheter.
  • the valve member (6) is placed into the cavity of the insert side (2) and the connective region (4).
  • the valve member (6) which consists of portions having different diameters, has a hole in the middle, one end of which is open and another end of which is close, is in the form of cylinder.
  • the valve member (6) is composed of four sections.
  • the valve member (6) comprises a first portion (7) which has a surface (11) isolated the valve member (6) from the external environment at the one end and another end of which is hollow, a expansion portion (8) which begins from the open end of the first portion (7) and enables the diameter of the hollow to increase by widening to the outwards, a middle portion (9) which extends below the expansion portion (8) in a constant diameter, and a fourth portion (10) which begins from the end of the middle portion (9), has a larger diameter than that of the middle portion (9) and extends in a constant diameter ( Figure 5, Figure 6 ).
  • Said first portion (7), said expansion portion (8) and said middle portion (9) is placed so as to coincide with the inside of the insert side (2), and the fourth portion (10) is placed so as to coincide with the inside of the connective region (4).
  • the valve member surface (11) at the end of the first portion (7) facing outside of the swabbable needleless valve (1) comprises at least one slit (12) in order to enable fluid introduction into the body (5).
  • Said slit (12) is in the closed state in a normal position, prevents anything out of the valve (1) from entering into the valve (1).
  • the slit (12) is opened by insertion of the male luer (M) of the medical devices such as sterile syringe, serum set, extension line which are used for administration of medicine and fluid into the insert side (2), and pushing the valve member (6) toward the connective region (4). Thereby, the fluid is enabled to pass to the exit side of the body (5) through the hole in the valve member (6) ( Figure 3 ).
  • At least one hollow canal (13) is provided on the external surface of the fourth portion (10) which comprises the valve member (6) and preferably has the largest diameter ( Figure 7 ).
  • the first portion (7), expansion portion (8) and middle portion (9) of the valve member (6) are enabled to be displaced to the connective region (4) by the male luer of the medical device inserted into the insert side (2) in order to perform fluid exchange.
  • the displaced valve member portions (7, 8, 9) cause said canal (13) to get narrower by elastic deformation; thereby the luer (M) is seated into the swabbable needleless valve (1) while the required volume is provided.
  • the canal (13) on the external surface of the fourth portion (10) is a vertical canal extending in parallel to the internal hollow of the fourth portion (10).
  • the surface on the inventive swabbable needleless valve (1) can be cleaned by being wiped.
  • Said surface (11) has a solid flat and smooth structure. Thereby, maximum safety is provided for the patient in the course of the treatment.
  • valve member (6) in the inventive swabbable needleless valve (1) is suitable for receiving the male luer (M) of syringes and serum sets used in the treatment.
  • the slit (12) on said valve member (6) is closed, whereby contact with the external environment is cut off.
  • a locking member (18) is provided between the connective region (4) and the leaning portion (15), on the flow cut-off portion (14).
  • the locking member (18) is in the shape of a rectangular plate on which there is a space width of which is getting decreased ( Figure 8 ).
  • the flow cut-off portion (14) stays in the wide part of the space on the locking member (18). Thereby, fluid flow is not occluded ( Figure 2 ).
  • valve member (6) returns back to the extending position while the locking member (18) is slid on the flow cut-off portion (14) and as a result of this sliding process it constrains the walls of the flow cut-off portion (14).
  • said locking member (18) and side walls of the flow cut-off portion (14) are constrained till the side walls contact with each other and so as not to exist a space therebetween ( Figure 4 ).
  • the constrained valve member (6) reverts to former shape, that is, due to volume and pressure difference to occur during opening of canals (13) on the fourth portion (10) again, blood flow from the catheter to the valve member (6) is prevented. Thereby, sucking of blood into the fluid passageway and occlusion by later clotting are prevented.
  • the body is in massive form.
  • the body is preferably made of thermoplastic elastomer or silicon.
  • the body's having massive structure (5) provides molding and assembling simplicity and reduces the cost.
  • the body (5) consists of two different parts.
  • insert side (2) and the connective portion (4) of the body (5) are manufactured as a single part and the exit side (3) of the same as another part. And then, these parts are connected to each other via the flow cut-off portion (14).
  • the flow cut-off portion (14) is manufactured from an elastic material such as thermoplastic elastomer, and the members composing the rest of the body is preferably manufactured from hard polycarbonate. Due to elasticity of the flow cut-off portion (14), it can be constrained by means of the locking member (18), whenever required, and thereby fluid flow is occluded.
  • Bodies composing of the invention can show variation in terms of sizes and quantities.
  • the number of the canals (13) included in the valve member (6) can vary from 2 to 10.
  • the geometry of these canals (13) which extend to cavity in the valve member (6) vertically, parallelly or angularly can be in the form of cylinder, semicircular cylinder, elliptical cylinder, square prism, rectangular prism, parallelogram prism, triangular prism, cone, inverted cone.
  • the fluid flow pathway is isolated from the external environment, whereby transmission of microorganisms to the vein of a patient is prevented.
  • the valve (1) is plain and has a limited number of parts, it is manufactured easily, cost effectively and serially.
  • Serum set or syringe tip can be easily inserted into and removed from the valve (1) easily, insert surface (11) of the valve reverts exactly to the original form after every insertion and removal. Due to the fact that the insert surface (11) of the valve (1) which is in contact with the external environment is plain and dead-spaceless, said surface (11) can be disinfected by being wiped easily before the syringe-serum set tip is inserted.
  • valve (1) has a fluid flow pathway which is wide, plain-smooth enough and there are not any obstacles such as dead space and joint in the fluid flow pathway, the valve does not restrict the flow by gravity force while the fluid is administered to a patient, and can be connected easily to every type of serum set and syringe tip.
  • the valve (1) reduces variety of devices (cap, needle, latex membrane cap, connector, cock, stopcock) used in the treatment, and enables total cost of the treatment to be reduced.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
EP10175695A 2009-09-08 2010-09-08 Valve sans aiguille écouvillonnable Withdrawn EP2292296A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
TR2009/06911A TR200906911A1 (tr) 2009-09-08 2009-09-08 Silinebilir iğnesiz valf.

Publications (1)

Publication Number Publication Date
EP2292296A1 true EP2292296A1 (fr) 2011-03-09

Family

ID=43259843

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10175695A Withdrawn EP2292296A1 (fr) 2009-09-08 2010-09-08 Valve sans aiguille écouvillonnable

Country Status (2)

Country Link
EP (1) EP2292296A1 (fr)
TR (1) TR200906911A1 (fr)

Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3994293A (en) 1974-05-07 1976-11-30 Crinospital S.P.A. Injector assembly for use in transfusions and perfusions
DE2817102A1 (de) 1978-04-19 1979-10-31 Fresenius Chem Pharm Ind Anschlusstueck fuer kunststoffkanuelen und gefaesskatheter
US5439451A (en) * 1994-03-22 1995-08-08 B. Braun Medical, Inc. Capless medical backcheck valve
US5676346A (en) 1995-05-16 1997-10-14 Ivac Holdings, Inc. Needleless connector valve
US5699821A (en) 1993-10-13 1997-12-23 Paradis; Joseph R. Control of fluid flow
WO1999013937A2 (fr) * 1997-09-15 1999-03-25 Alaris Medical Systems, Inc. Soupape sans aiguille
US6036171A (en) 1997-09-17 2000-03-14 Halkey-Roberts Corporation Swabbable valve assembly
US6039302A (en) 1996-11-18 2000-03-21 Nypro Inc. Swabbable luer-activated valve
US6079432A (en) 1996-07-02 2000-06-27 Paradis; Joseph R. Control of fluid flow by oval shaped valve member containing a cam interface
US6177037B1 (en) * 1994-06-20 2001-01-23 Becton, Dickinson And Company Method of forming a slit in a reseal element for a needleless injection site
US6651956B2 (en) 2002-01-31 2003-11-25 Halkey-Roberts Corporation Slit-type swabable valve
WO2006103792A1 (fr) * 2005-03-28 2006-10-05 Kabushiki Kaisha Top Connecteur
US20070218757A1 (en) * 2006-03-17 2007-09-20 Industrie Borla S.P.A. Valve connector for medical lines
US20070225660A1 (en) * 2006-03-16 2007-09-27 Lynn Lawrence A Swab pouch
WO2008058133A2 (fr) * 2006-11-06 2008-05-15 Becton, Dickinson And Company Ventilation du boîtier d'un dispositif d'accès vasculaire

Patent Citations (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3994293A (en) 1974-05-07 1976-11-30 Crinospital S.P.A. Injector assembly for use in transfusions and perfusions
DE2817102A1 (de) 1978-04-19 1979-10-31 Fresenius Chem Pharm Ind Anschlusstueck fuer kunststoffkanuelen und gefaesskatheter
US4387879A (en) 1978-04-19 1983-06-14 Eduard Fresenius Chemisch Pharmazeutische Industrie Kg Self-sealing connector for use with plastic cannulas and vessel catheters
US5699821A (en) 1993-10-13 1997-12-23 Paradis; Joseph R. Control of fluid flow
US5439451A (en) * 1994-03-22 1995-08-08 B. Braun Medical, Inc. Capless medical backcheck valve
US6177037B1 (en) * 1994-06-20 2001-01-23 Becton, Dickinson And Company Method of forming a slit in a reseal element for a needleless injection site
US5676346A (en) 1995-05-16 1997-10-14 Ivac Holdings, Inc. Needleless connector valve
US6079432A (en) 1996-07-02 2000-06-27 Paradis; Joseph R. Control of fluid flow by oval shaped valve member containing a cam interface
US6039302A (en) 1996-11-18 2000-03-21 Nypro Inc. Swabbable luer-activated valve
WO1999013937A2 (fr) * 1997-09-15 1999-03-25 Alaris Medical Systems, Inc. Soupape sans aiguille
US6036171A (en) 1997-09-17 2000-03-14 Halkey-Roberts Corporation Swabbable valve assembly
US6651956B2 (en) 2002-01-31 2003-11-25 Halkey-Roberts Corporation Slit-type swabable valve
WO2006103792A1 (fr) * 2005-03-28 2006-10-05 Kabushiki Kaisha Top Connecteur
US20070225660A1 (en) * 2006-03-16 2007-09-27 Lynn Lawrence A Swab pouch
US20070218757A1 (en) * 2006-03-17 2007-09-20 Industrie Borla S.P.A. Valve connector for medical lines
WO2008058133A2 (fr) * 2006-11-06 2008-05-15 Becton, Dickinson And Company Ventilation du boîtier d'un dispositif d'accès vasculaire

Also Published As

Publication number Publication date
TR200906911A1 (tr) 2010-12-21

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